# HIPAA (45 CFR Part 164) 164.306(a) — General Requirements - Source: https://support.icompaas.com/compliance/hipaa/164-306-a-general-requirements - Section: [Compliance](https://support.icompaas.com/compliance) › [HIPAA Security, Privacy & Breach-Notification Rules](https://support.icompaas.com/compliance/hipaa) › Security Rule — §164.306 - Last updated: 2026-06-05 - Publisher: iCompaas, Inc. (https://www.icompaas.com) **HIPAA (45 CFR Part 164)**·§ `164.306(a)`·medium·Component: **Security Rule** ## What this control requires > Covered entities and business associates must do the following: (1) Ensure the confidentiality, integrity, and availability of all electronic protected health information the covered entity or business associate creates, receives, maintains, or transmits. (2) Protect against any reasonably anticipated threats or hazards to the security or integrity of such information. (3) Protect against any reasonably anticipated uses or disclosures of such information that are not permitted or required under subpart E of this part; and (4) Ensure compliance with this subpart by its workforce. > > — HIPAA (45 CFR Part 164), § 164.306(a) ### In plain English Covered entities and business associates must do the following: (1) Ensure the confidentiality, integrity, and availability of all electronic protected health information the covered entity or business associate creates, receives, maintains, or transmits. In practice, this means you can prove you general requirements-level controls on a defined cadence. ## Why it matters HIPAA non-compliance is a strict-liability matter: OCR civil monetary penalties are assessed per-record per-violation (up to USD 1.9 million per identical-violation calendar year as of 2024), and willful neglect can trigger criminal referral. ## What an auditor looks for HHS OCR investigators and SOC-2+HIPAA auditors look for the specific 45 CFR § citation, whether the safeguard is required vs addressable (and if addressable, the documented decision), the implementation specification, the workforce member responsible, and the records that show it runs. Within **Security Rule**, the assessor will trace your implementation back to the catalogue reference (§ 164.306(a)) and look for objective evidence on the latest two assessment cycles. ## How to implement #### Policy Management **Docs.** Keep each policy in version-controlled Markdown alongside the code that implements it; ship a signed PDF snapshot at each annual review and link the SHA into the SoA. ### Operational checklist - **General.** Document the trigger, the owner and the cadence. - **Security.** Document the trigger, the owner and the cadence. - **Workforce.** Document the trigger, the owner and the cadence. - **Information.** Document the trigger, the owner and the cadence. - **Business.** Document the trigger, the owner and the cadence. - **Scope:** requirements, security, management, availability, business associate, policy, e, uses. ## Evidence to collect - **Policy Document.** A signed and version-controlled policy / standard / procedure document. Signed policy or standard documents the safeguard. Focus: General Requirements. ## Common pitfalls - Policies that no engineer has read; the version in Confluence drifts from the version that's actually being enforced. ## How it maps to other frameworks Computed from shared tags, control component and key-operation subjects — handy when you are reconciling controls across an audit. - [**ISO/IEC 27001:2022 A.8.26** — Application security requirements](https://support.icompaas.com/compliance/iso-27001-2022/a-8-26-application-security-requirements) - [**BSI C5:2020 SP-01** — Documentation, communication and provision of policies and instructions](https://support.icompaas.com/compliance/bsi-c5-2020/sp-01-documentation-communication-and-provision-of-policies-and-instructions) - [**NIST SP 800-53 Rev. 5 PL-2(1)** — Concept Of Operations](https://support.icompaas.com/compliance/nist-sp-800-53-rev-5/pl-2-1-concept-of-operations) - [**NIST SP 800-171 Rev. 3 3.12.1** — Security Assessment](https://support.icompaas.com/compliance/nist-sp-800-171-rev-3/3-12-1-security-assessment) ## Related controls in HIPAA (45 CFR Part 164) - [**§ 164.308(a)(8)** — Evaluation](https://support.icompaas.com/compliance/hipaa/164-308-a-8-evaluation) - [**§ 164.314(a)(2)(i)(A)** — Business associate contracts](https://support.icompaas.com/compliance/hipaa/164-314-a-2-i-a-business-associate-contracts) - [**§ 164.314(a)(2)(i)(C)** — Business associate contracts.](https://support.icompaas.com/compliance/hipaa/164-314-a-2-i-c-business-associate-contracts) - [**§ 164.308(a)(1)(ii)(A)** — Security Management Process - Risk Analysis](https://support.icompaas.com/compliance/hipaa/164-308-a-1-ii-a-security-management-process-risk-analysis) - [**§ 164.314(a)(2)(iii)** — Business associate contracts with subcontractors](https://support.icompaas.com/compliance/hipaa/164-314-a-2-iii-business-associate-contracts-with-subcontractors) - [**§ 164.308(a)(4)(ii)(C)** — Information Access Management - Access Establishment and Modification](https://support.icompaas.com/compliance/hipaa/164-308-a-4-ii-c-information-access-management-access-establishment-and-modification) ## References - [U.S. HHS Office for Civil Rights — HIPAA (45 CFR Part 164)](https://www.hhs.gov/hipaa/for-professionals/index.html) - Catalogue identifier: `§ 164.306(a)` Topics: governance riskpolicy management ## Related compliance guidance - [HIPAA compliance for SaaS: a practical implementation guide](https://support.icompaas.com/compliance/hipaa): Start with the full HIPAA implementation guide — scope, roadmap, evidence and how the assessment runs. - [SOC 2 compliance: a practical implementation guide for cloud-native SaaS teams](https://support.icompaas.com/compliance/soc-2-trust-services-criteria): Most covered-entity customers accept a SOC 2 Type II report as the independent evidence that your HIPAA controls operate, since no HIPAA attestation exists. - [NIST SP 800-53 Rev. 5: a practical implementation guide for cloud teams](https://support.icompaas.com/compliance/nist-sp-800-53-rev-5): NIST publishes mappings of the Security Rule standards and implementation specifications to SP 800-53 Rev. 5 controls alongside SP 800-66 Rev. 2, so an 800-53 control set doubles as a HIPAA crosswalk.